Registration Dossier
Registration Dossier
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EC number: 812-222-2 | CAS number: 4443-23-6
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-07-23 to 2018-09-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Key result
- Water solubility:
- 189 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- 4.6
- Remarks on result:
- other: No Tyndall-effect was observed for any of the centrifuged samples.
- Conclusions:
- The solubility of the test item was determined at 20 ± 0.5°C to be 189 g/L (pH 4.6) for the samples with pre-incubation times of 24, 48 and 72 h.
Reference
Validity criteria:
The study was performed based on OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The validity criteria were fulfilled:
- The concentration measured at each sampling time did not differ for more than 15%.
- Temperatures were kept constant within ± 0.5 °C.
Water solubility results at 20°C:
Preincubation time |
Replicate No. |
Test item [mg/L] |
|
Concentration |
Mean |
||
24 h |
1 |
192 |
190 |
2 |
188 |
||
48 h |
1 |
186 |
188 |
2 |
189 |
||
72h |
1 |
190 |
189 |
2 |
188 |
||
Mean (24 – 72h) |
|
|
189 |
Deviation [%] (24 – 72h) |
1.0 |
||
The analytical method (HPLC-DAD, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
Description of key information
The solubility of the test item was determined at 20 ± 0.5°C to be 189 g/L (pH 4.6) for the samples with pre-incubation times of 24, 48 and 72 h.
Key value for chemical safety assessment
- Water solubility:
- 189 g/L
- at the temperature of:
- 20 °C
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
